Instrumentation Laboratory Co. Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in re Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance RecombiPlasTin after reconstitution with Hemoliance RecombiPlasTin Diluent is a liposomal preparation of recombinant human tissue factor and purified phospholipids, calcium chloride, buffer and a preservative. The use of recombinant human tissue factor and purified phospholipids assures uniformity in re
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
Product No.49732750 (5 mL): Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152, Product No. 49732720 (20 mL): Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409, N0353410, N0454257, N0857199, N1050143.
Products Sold
Product No.49732750 (5 mL): Lots N0448239, N0549190, N0940581, N0353406, N0857200, N1050152; Product No. 49732720 (20 mL): Lots N0347895, N0548959, N0749495, N0940543, N0940586, N1242409, N0353410, N0454257, N0857199, N1050143.
Instrumentation Laboratory Co. is recalling Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of H due to Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CU. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).
Recommended Action
Per FDA guidance
"Urgent Product Notifications" were sent to IL customers on 3/07/06 through its distributor, Beckman Coulter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026